Retiro De Equipo (Recall) de Brilliance iCT and iCT SP up to and including Software Version 3.2.5

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Philips Electronics Australia Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
  • ID del evento
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    When using 80kvp with intravenous contrast in head and neck studies with u-filters (ua, ub, uc), a vascular artefact that resembles thrombus may appear on the image. there is a risk of misdiagnosis which can lead to unnecessary treatment of a patient. for certain patient populations, this could contribute to serious injury.
  • Acción
    When the settings (80 kVp with intravenous contrast in head and neck studies with U-filters (UA, UA and UC)) are used, Philips recommends performing additional reconstruction with a non-U filter and comparing the result images to verify no such artefact is evident. Customers are advised to continue to use 80 kVp with U-filters for brain perfusion scans. Refer to the Instructions for Use (IFU) for the selection of an arterial input unaffected by discontinuity should one occur.



  • Empresa matriz del fabricante (2017)
  • Source